MAUDE Adverse Event Report: VYAIRE MEDICAL, INC ELECTRODES, FETAL SCALP (FSE), 50/CASE; ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR

Catalog Number 7000AAO

Device Problem Failure to Disconnect (2541)

Patient Problem Pregnancy (3193)

Event Date 11/27/2017

Event Type  Injury  

Manufacturer Narrative

No sample was provided for evaluation.If a sample or any additional information becomes available a follow up submission will be filed.

Event Description

The scalp electrodes are not coming off the baby's head prior to delivery.When the physicians or nursing staff have gone to remove the fetal scalp electrodes from the infants head it would not unscrew.They cut the pink and blue cord, separate the cords as instructed, which is suppose to unscrew the electrode.In the case where it would not come off the fetal scalp we have had to cut the cords very short and deliver the baby via cesarean section and remove the scalp electrodes from the baby's head.This puts the mom at a greater risk for infection since we are bringing the cords through the vagina into the uterus.The physicians are the ones who place the fetal scalp electrodes on the infants head.The cords involved have all been disposed of, because they were used.

• Brand Name: ELECTRODES, FETAL SCALP (FSE), 50/CASE
• Type of Device: ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 26125 north riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): PRECISION CONCEPTS COSTA RICA SA; saret industrial park; building d; rio segundo/ alajuela 74400 2; CS 744002
• Manufacturer Contact: mindy faber ; 26125 north riverwoods blvd.; mettawa, IL 60045
• MDR Report Key: 7213617
• MDR Text Key: 98024857
• Report Number: 2050001-2018-00092
• Device Sequence Number: 1
• Product Code: HGP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K792669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7000AAO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention